Official Title: “Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy”

The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
  • olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
• Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
  • olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
• Drug: olmesartan medoxomil/hydrochlorothiazide tablets
  • olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
• Drug: olmesartan medoxomil/hydrochlorothiazide tablets
  • olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 4
  • olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
• Experimental: 1
  • olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
• Experimental: 3
  • olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
• Experimental: 2
  • olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Primary Measures

• Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
  • Time Frame: 8 weeks, change = week 16 - week 8
    Safety Issue?: No

Secondary Measures

• Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
  • Time Frame: 4 weeks, change = week 12 - week 8
    Safety Issue?: No
• Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
  • Time Frame: 8 weeks, change = week 16 - week 8
    Safety Issue?: No
• Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
  • Time Frame: 4 weeks, change = week 12 - week 8
    Safety Issue?: No
• Number of Patients Achieving Target Blood Pressure at Week 16
  • Time Frame: 8 weeks
    Safety Issue?: No
• Change in Mean 24-Hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
  • Time Frame: 8 weeks, change = week 16 - week 8
    Safety Issue?: No
• Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
  • Time Frame: 8 weeks, change = week 16 - week 8
    Safety Issue?: No
• Change in Mean Night-Time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
  • Time Frame: 8 weeks, change = week 16 - week 8
    Safety Issue?: No

Inclusion Criteria:

• Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)

Exclusion Criteria:

• Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
• Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
• Patients having a history of the following within the last six months:
• myocardial infarction,
• unstable angina pectoris,
• percutaneous coronary intervention,
• severe heart failure,
• hypertensive encephalopathy,
• cerebrovascular accident (stroke) or
• transient ischaemic attack.
• Patients with clinically significant abnormal laboratory values at screening.
• Patients with secondary HTN.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Daiichi Sankyo Inc.

Overall Clinical Trial Officials and Contacts

Professor Lars Christian Rump, M.D. Study Chair University of Ruhr-Bochum  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00430508

Study ID Number: CS866CM-B-E301

ClinicalTrials.gov Identifier: NCT00430508

Health Authority: EU: EMEA